BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6168976 · Received December 13, 2016

    Report

    Report Number
    9710107-2016-01131
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WERE RECEIVED FOR EVALUATION AND INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE DELIVERY SYSTEM AND CAPSULE WERE DISINFECTED AND THE LOT NUMBER AND ID# MATCHED THE INFORMATION PROVIDED BY THE INITIAL REPORTED. THE TROCAR NEEDLE WAS ADVANCED. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY PROCEDURE WAS NOT IMPLEMENTED AND THE CAPSULE ELECTRODES WERE OKAY. THE DELIVERY SYSTEM DID NOT HAVE ANY OTHER VISIBLE DAMAGE. PER THE CONDITION IN WHICH THE DEVICE WAS RECEIVED, THE DELIVERY SYSTEM AND CAPSULE SEEMED TO BE FUNCTIONING PER SPECIFICATION. THERE WAS EVIDENCE OF MISHANDLING WITH THE PLUNGER ROTATED MORE THAN 1/8 OF A TURN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED LOT / SERIAL NUMBER WAS COMPLETED AND INDICATES ALL PARAMETERS AND ACCEPTANCE CRITERIA FOR ENTRIES POTENTIALLY PERTINENT TO THE REPORTED EVENT WERE WITHIN SPECIFIED LIMITS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE BRAVO CAPSULE FAILED TO ATTACH. THERE WAS NO HARM CAUSED TO THE PATIENT. A REPEAT BRAVO PROCEDURE WAS PERFORMED. THERE NOTHING UNUSUAL ABOUT THE PATIENT OF THE PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821444 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 31839Q

    Patients

    Seq Age Sex Outcome Treatment
    1